Curriculum Vitae

Shivkumar S. Hatti, M.D., M.B.A.

• 1995-1997 Executive MBA at St. Joseph's University in Philadelphia, PA.
• 1982-1992 Psychoanalytic Training at Philadelphia Association for Psychoanalysis, Philadelphia, PA.
• 1977-1980 General Psychiatric residency, Thomas Jefferson University, Philadelphia.
• 1975-1976 Residencies in General Internal Medicine and Dermatology, Bombay, India.
• 1969-1975 Bachelor of Medicine/Bachelor of Surgery (M.B.B.S.) Seth G.S. Medical College and K.E.M. Hospital, Bombay University, Bombay, India. Recipient of National Open Merit Scholarship.

Licenses & Certifications:

• 2003 GCP Course Certification
• 1981 Board Certification in General Psychiatry
• 1977 Licensed to practice in State of Pennsylvania

Work Experience:

2003-Present Sequoia Behavioral Health Care LLC.

• Provide direct patient care in Media, PA
• Manage MD contracts with various agencies in Delaware, Chester, Philadelphia and Montgomery Counties
• Consultant Medical Director, Chester County Dept of Human Services and Montgomery County Behavioral Health

January, 2001-Present Suburban Research Associates

• Chief Executive Officer and Principal Investigator.
• Supervising two clinical coordinators, one rater, one administrator, and two sub investigators.
• Currently conducting studies in Schizophrenia, Attention Deficit Hyperactivity Disorder, Major Depression, Generalized Anxiety Disorder, Bipolar Disorder, and Panic Disorder

1989 -2003 Chairman and Chief Executive Officer, Suburban Psychiatric Associates, Media PA.

• Founder of behavioral health multispeciality group, the only physician-owned and managed behavioral medicine group in region.
• Managed HAI - RISK contract for 250,000 enrollees in Eastern PA and Delaware.
• Provided medical leadership at Help Counseling Inc., Chester County Mental Health Center.
• Developed contracts for 16 nursing homes.
• Supervised 60 employees and 400 contractors.
• Developed Mental retardation consults with Elywn, Deveraux, Rose Hill, Chester, and Delaware County mental retardation agencies.
• Increased revenue from $300,000 in 1989 to $4.2 Million in 1997 and remained at that level until July, 2001
• Provided Psychiatric Services to two residential addiction programs in Delaware County

1993-1997 Awarded professional management contract at Crozer Chester Medical Center (CCMC).

• Coordinated and co-managed all clinical programs in behavioral medicine at CCMC.
• Active on various committees: Chaired: Ethics Committee - Community Hospital Physicians Health Committee - Community Hospital Quality Assurance Committee - CCMC

Community Hospital (Sacred Heart Medical Center)
                  Pharmacy and Therapeutic Committee
                  Medical Executive Committee
                  Intern and House Staff Committee
                  Department of Psychiatry Quality Assurance Committee
                  Finance Committee

Crozer Keystone Health Systems (CKHS)
                  Board Director - Crozer Keystone Health Systems
                  Board Director - Health Access Board
                  Managed Care Executive Committee
                  Quality of Care Committee
                  Behavioral Health Institute Planning Committee
                  Health Access Board Finance Committee

Managed Care Enterprises
                  Board Director

U.S. Health Care
                  National Quality Assurance Committee in Behavioral                   Health
                  Co-Chair - committees to develop outcome data in                   behavioral health

1982-1993 Medical Director and Chairman of Department Psychiatry, Psychiatric Unit at Sacred Heart Medical Center, Chester, PA. (Contract basis 1989-1993; part-time 1982-1989)

• Oversaw expansion from 22-bed to 72 beds.
• Increased percentage of managed care patients from 1% to 30% in 2 years.
• Initiated and developed new creative programs to satisfy community needs and to position psychiatric department for future challenges: Established 23-hour observation unit; Psycho Geriatric unit; Dual diagnosis unit (Addiction and Psychiatry); and Psychiatric Unit for mentally retarded and Medical Detox Unit

Research, Publications, Teaching & Presentations:

1981-Present  Assistant Clinical Professor, Thomas Jefferson University, Philadelphia, PA.

• Consultations and presentations to professional groups (such as American Psychiatric Association's and Pennsylvania Psychiatric Society's Annual Meetings).  Topics include:
  • Managed Care
  • Development of new behavior health systems
  • Formulation of new professional groups
  • Development of RISK contracts
  • Administrative Psychiatry
• On Speakers Bureau for Eli Lilly, Forrest, and Smithkline & French Laboratories
• Authored  
  • Hatti, S, Dubin WR, Weiss J:  "A Study of Circumstances Surrounding Patient Assaults on Psychiatrists."  Hospital and Community Psychiatry 33:660-661
  • Dubin WR, Hatti S: "Developing a Continuum of Care: The Treatment Paradigm for the 21st Century," in Behavioral Health Services Delivery: Models and Methods, Boruch F (ed). The American College of Physician Executives, Tampa, Fl, 1998.

Research

Major Depression

• Long-Term Open Label Treatment with R- Fluoxetine for the Evaluation of Safety in Major Depression.  Sponsor: Eli Lilly, 24 subjects enrolled/10 months, 1999 (Phase III).

• Long Term Open Label Treatment with Duloxetine HCI for Evaluation of Safety in Major Depression.  Sponsor: Eli Lilly, 8 subjects enrolled/4 months, 2000 (Phase II).

• The Combination of Olanzapine and Fluoxetine in Treatment Resistant Depression without Psychotic Features.  Sponsor: Eli Lilly, 8 subjects enrolled/3 months, 2000 (Phase III).

• Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder.  Sponsor: Eli Lilly, 18 subjects enrolled over 4 months, 2002 (Phase III).

• Examining Clinical Experience with Escitalopram in Depression.  Sponsor: Forest Laboratories, 3 subjects enrolled/2 months, 2003 (Phase IV).

• Duloxetine vs. Escitalopram and Placebo in the Treatment of Patients with Major Depression.  Sponsor: Eli Lilly, 24 subjects enrolled/6months, 2004 (Phase III).

• Open Label Duloxetine Compassionate Use in Patients Who Have Completed a Previous Neuroscience Duloxetine Clinical. Trial  Sponsor: Eli Lilly, 5 Subjects enrolled, 2004 (Phase III).

• Fixed Dose Comparison of Escitalopram Combination Treatment in Adult Patients with Major Depressive Disorder.  Sponsor: Forest Laboratories, 2005 (Phase IV).  Enrollment set to begin April 2005.

• A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Aripiprazole as Adjunctive Therapy in the Treatment of Patients with Major Depressive Disorder. Sponsor- Bristol-Myers Squibb, 2006 (Phase III).

• A Multicenter, Double-Blind, Randomized-withdrawal, Parallel-group Placebo-controlled Phase III Study of the  Efficacy and Safety of Quetiapine Fumarate Sustained Release as Monotherapy in the Maintenance Treatment of Patients with Major Depressive Disorder Following an Open-Label Stabilization Period. Sponsor: Astra Zeneca, 2006 (Phase III).

• Fixed Dose Comparison of Escitalopram to Active comparator in Moderately-to Severely Depressed Patients.  Sponsor: Forest, 2006.

Attention Deficit/Hyperactivity Disorder

• A Phase III Open-Label and Efficacy Study of Tomoxetine HCL in Pediatric Outpatients with ADHD. Sponsor: Eli Lilly, 1999.

• Safety and Efficacy of Tomoxetine or Tomoxetine Plus Fluoxetine in the Treatmentof Mixed Attentional and Affective Disorders. Sponsor: Eli Lilly, 2000 (Phase III).

• Long term, Open label, Safety Study of Atomoxetine Hydrochloride in Patients 6 years and Older with ADHD. Sponsor: Eli Lilly, 2002.

• A Double-Blind Placebo-Controlled Study of Atomoxetine Hydrochloride in the Treatment of Adults with ADHD and Co morbid Social Anxiety Disorder. Sponsor: Eli Lilly, 2006

• A Randomized, Double-Blind Comparison of Placebo and Atomoxetine HCI Given Once a Day in Adults with ADHD: with a Secondary Examination of Impact of Treatment on Family Functioning. Sponsor Eli Lilly, 2006

Bipolar

• Topiramate Versus Placebo as Add-On Treatment in Subjects with Bipolar Disorder in the Outpatient Setting. Sponsor: Ortho-McNeil, 2002 (Phase III).

• Optimizing Administration of Lamictal: SCA40917 An open-label study of tolerability, clinical response and satisfaction in adult and adolescent bipolar I subjects optimizing initiation of therapy using administration of dermatological precautions and Lamictal titration pacts. Sponsor: GlaxoSmithKline, 2003.

• Olanzapine/Fluoxetine Combination vs Lamotrigine in the Treatment of Bipolar I Depression. Sponsor: Eli Lilly, 2004 (Phase III).

• Olanzapine vs Valproate and Placebo in the Treatment of Mild to Moderate Mania Associated w/ Bipolar Disease. Sponsor: Eli Lilly, 2004 (Phase III).

• A Multicenter, Randomized, Parallel-group, Double-blind, Phase III Comparison of the Efficacy and Safety of Quetiapine Fumarate to Placebo When Used as Adjunct to Mood Stabilizers in the Maintenance Treatment of Bipolar I Disorder in Adult Patients. Sponsor: Astra Zeneca, 2005 (Phase III).

• A Multicenter, Randomized, Parallel-group, Double-blind, Phase III Comparison of the Efficacy and Safety of Quetiapine Fumarate to Placebo When Used as Adjunct to Mood Stabilizers in the Maintenance Treatment of Bipolar I Disorder in Adult Patients with Alcohol Dependence. Sponsor: Astra Zeneca, 2005 (Phase III).

• A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients with Bipolar I Disorder with a Major Depressive Episode. Sponsor: Bristol-Myers Squibb, 2005 (Phase III).

• Efficacy of Aripiprazole in Combination with Valproate or Lithium in the Treatment of Mania in Patients with Bipolar I Disorder Partially Nonresponsive to Valproate or Lithium Monotherapy. Sponsor: Bristol-Myers Squibb, 2006.

Borderline Personality Disorder

• Efficacy and Safety of Olanzapine in Patients with Borderline Personality Disorder: A Randomized Flexible Dose Double-Blind Comparison with Placebo. Sponsor: Eli Lilly, 2004 (Phase III).

Enuresis

• Placebo Controlled Study of the Effects of Atomoxetine Hydrochloride on Bladder Control in Children with Nocturnal Enuresis. Sponsor: Eli Lilly, 2002 (Phase III).

Generalized Anxiety Disorder

• Double-Blind, Placebo-Controlled Study of Venlafaxine ER in Children and Adolescents with Generalized Anxiety Disorder. Sponsor: Wyeth Ayerst Research, 2000 (Phase III).

• Duloxetine HCI Once Daily Compared with Placebo in the Treatment of GAD. Sponsor: Eli Lilly, 2004 (Phase III).

• A Randomized, Double-Blind, Placebo and Active Comparator Controlled, Parallel Group Safety and Efficacy Study of Oros Alprazolam in Adults with Generalized Anxiety Disorder. Sponsor: Jazz Pharmaceuticals, 2005 (Phase III).

• A 28 Day, Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Safety and Efficacy Study of Ocinaplon in Patients with Generalized Anxiety. Sponsor: DOV Pharmaceuticals, 2005 (Phase III).

• Duloxetine 60 to 120 mg Once Daily Compared with Placebo in the Prevention of Relapse in Generalized Anxiety Disorder. Sponsor: Eli Lilly, 2006 (Phase III).

•  A Phase 2 Randomized, Double-Blind, Placebo Controlled, Parallel Group, 5 Week Trial to Assess the Efficacy and Safety of PD 0332334 Compared to Placebo and Alprazolam Extended-Release in Patients with Generalized Anxiety Disorder. Sponsor: Pfizer,  2006 (Phase II).

• An Eight-Week, Multicenter, Randomized, Double-blind, Placebo Controlled Study, with Escitalopram as an Active Control, to Evaluate the Efficacy, Safety and Tolerability of Saredutant 100mg Dose Once Daily, in Patients with Generalized Anxiety Disorder. Sponsor: Sanofi Aventis 2006 (Phase II)

Insomnia

•    A Comparison of Zolpidem MR vs. Placebo in the Treatment of Insomnia Associated with Newly Diagnosed Major Depressive Disorder (MDD) or Untreated MDD Relapse when used Concomitantly with Escitalopram. Sponsor: Sanof-Aventis, 2006 (Phase III)

•  A Comparison of Zolpidem MR vs. Placebo in the Treatment of Insomnia Associated with Generalized Anxiety Disorder (GAD) when used Concomitantly with Escitalopram. Sponsor: Sanof-Aventis, 2006 (Phase III)

Panic Disorder

• A Randomized, double-blind, placebo-controlled study of continuation treatment with Xanax XR in the treatment of adolescents with a primary diagnosis of panic disorder. Sponsor: Pfizer, 2004 (Phase III).

Schizophrenia

• A Prospective, Multicenter, Open-Label Study of Aripiprazole in the Management of Patients with Schizophrenia or Schizoaffective Disorder in General Psychiatric Practices. Sponsor: Bristol-Myers Squibb, 2002.

• An International, Multicenter, Large Simple trial to Compare the Cardiovascular Safety of Ziprasidone and Olanzapine. Sponsor: Pfizer, 2002 (Phase IV).

• A Randomized Double-Blind Study of Olanzapine vs. Aripiprazole in the Treatment of Schizophrenia. Sponsor: Eli Lilly, 2004-2005 (Phase III).

• A multicenter, open label, flexible-dose, parallel-group evaluation of the cataractogenic potential of quetiapine fumarate and risperidone in the long-term treatment of patients with schizophrenia or schizoaffective disorder. Sponsor: Astra Zeneca, 2005.

• A Randomized, Open-Label Study Comparing the Effects of Olanzapime Pamoate Depot with Oral Olanzapine on Treatment Outcomes in Outpatients with Schizophrenia.  Sponsor: Eli Lilly 2006 (Phase III).

• A Multicenter, Randomized, Double-Blind, Placebo Controlled, 16-Week Study of Aripiprazole Used as Dual therapy in the Treatment of Patients with Chronic Stable Schizophrenia or Schizoaffective Disorder Demonstrating and Inadequate Response to Quetiapine or Risperidone Monthotherapy. Sponsor: Bristol-Myers Squibb Company, 2006.

Social Anxiety Disorder

• A Randomized, Double Blind Comparison of XXXXX, Paroxetine, and Placebo in the Treatment of SAD. Sponsor: Eli Lilly, 2005 (Phase II).
  
•  A Double-Blind Placebo-Controlled Study of Atomoxetine Hydrochloride in the Treatment of Adults with ADHD and Co-morbid Social Anxiety Disorder. Sponsor: Eli Lilly, 2006 (Phase III)
  
• A Randomized Double Blind Comparison of XXXX, Paroxetine and Placebo in the treatment of SAD. Sponsor: Glaxo Smith Kline, 2007 (Phase II).

Stuttering

• A 3-arm, double-blind, placebo-controlled clinical trial to assess the efficacy, safety and tolerability of pagoclone for treatment of adults with stuttering.  Sponsor: Indevus Pharmaceuticals, Inc, 2009 (Phase II)

 Proficient In The Following Psychiatric Rating Scales:

•  Abnormal Involuntary Movement Scale (AIMS)
• ADHD Ratings -IV (DuPaul)
• Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog)
• Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)
• Barnes Akathisia Rating Scale
• Beck Depression Inventory
• Brief Psychiatric Rating Scale (BPRS)
• Calgary Depression Scale
• Children's Depression Inventory (CDI)
• Children's Depression Rating Scale (CDRS)
• Clinical Global Impression (CGI)
• Clinician Interview Based Impression of Change plus Caregiver Input (CIBIC-plus)
• Columbia - Suicide Severity Rating Scale (C-SSRS)
• Conner's Parent Rating Scale
• Diagnostic Interview for Children and Adolescents (DICA)
• Diagnostic Interview Schedule for Children (DISC)
• Drug Attitude Inventory (DAI)
• Generalized Anxiety Disorder-7 (GAD-7)
• Geriatric Depression Scale (GDS)
• Global Assessment of Functioning Scale (GAF)
• Hamilton Anxiety Scale ( HAMA)
• Hamilton Depression Rating Scale (HAMD)
• Harvard Department of Psychiatry and National Depression Screening Day Scale (HANDS)
• Leibowitz Social Anxiety Scale (LSAS)
• Major Depression Inventory (MDI)
• Mini International Neuropsychiatric Interview (MINI)
• Mini Mental Status Examination (MMSE)
• Montgomery and Asberg Depression Rating Scale (MADRS)
• Neuropsychiatric Inventory (NPI)
• Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
• Primary Care Evaluation of Mental Disorders (PRIME-MD)
• Quick Inventory of Depressive Symptomatology Clinician Rated (QIDS-C)
• Scale for the Assessment of Negative Symptoms (SANS)
• Scale for the Assessment of Positive Symptoms (SAPS)
• Schedule for Affective Disorder and Schizophrenia in Children (K-SADS)
• Simpson Angus Scale for EPS
• Structured Clinical Interview for DSM-IV (SCID)
• Structured Clinical Interview for DSM-IV Axis II Disorders (SCID II)
• Yale Brown Obsessive Compulsive Scale (YBOCS)
• Young Mania Rating Scale (YMRS)

Membership

• Member:
  • Pennsylvania County Medical Society
  • American Psychiatric Association (APA)
  • American Academy of Pharmaceutical Physicians (AAPP)
• President Elect: Indo American Psychiatric Association (IAPA)
  
• Immediate Past President: American Association of Psychiatric Administrators (AAPA)
• Treasurer: Delaware County Medical Society
• President: Philadelphia Psychiatric Society